ACETAMEX 250 MG 20 TABS.

Important Disclaimer: This summary is for educational and informational purposes only and should not, under any circumstances, replace direct consultation with a qualified physician or pharmacist. Always refer to the product’s internal leaflet or consult a healthcare professional before use.

Drug Name: ACETAMEX 250 MG 20 TABS.

Manufacturer:

ACETAMEX 250 MG 20 TABS. is manufactured by HI-PHARM, Egypt – a well-established pharmaceutical company known for producing a wide range of generic and specialty medications across various therapeutic categories. [1, 2]

Introduction:

ACETAMEX 250 mg contains Acetazolamide, a potent carbonic anhydrase inhibitor. It is primarily used as a diuretic, but its mechanism of action also makes it effective in treating conditions like glaucoma (by reducing intraocular pressure), certain types of epilepsy, and altitude sickness. Acetazolamide works by reducing the formation of bicarbonate and hydrogen ions, leading to altered fluid and electrolyte balance in various tissues. [3, 4]

Indications and Usage:

ACETAMEX 250 MG is indicated for the management of: [3, 4, 5]

• Glaucoma: To reduce intraocular pressure in chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute congestive (angle-closure) glaucoma.
• Acute Mountain Sickness (AMS): For prevention and treatment of symptoms like headache, nausea, dizziness, and fatigue at high altitudes.
• Epilepsy: As an adjunct to other anticonvulsants in various types of epilepsy (e.g., petit mal, grand mal, mixed seizures).
• Edema: As a diuretic in cases of fluid retention associated with congestive heart failure, drug-induced edema, and premenstrual tension.
• Periodic paralysis (hypokalemic): (Off-label use).

Characteristics:

Acetazolamide is a potent carbonic anhydrase inhibitor. In the kidney, it inhibits carbonic anhydrase in the renal tubules, leading to increased excretion of bicarbonate, sodium, potassium, and water, thus producing a diuretic effect. In the eye, it reduces the formation of aqueous humor, thereby lowering intraocular pressure. In the central nervous system, its inhibitory action on carbonic anhydrase may help to stabilize neuronal membranes, contributing to its anticonvulsant effects. [3, 4, 6]

• Active Ingredient: Acetazolamide 250 mg per tablet.
• Form: Tablets.
• Pack Size: 20 tablets.
• Drug Class: Carbonic Anhydrase Inhibitor, Diuretic, Anticonvulsant.
• Mechanism of Action: Inhibits carbonic anhydrase enzyme, reducing reabsorption of bicarbonate in renal tubules, leading to mild diuresis, reduction in aqueous humor production (for glaucoma), and CNS excitability modulation (for seizures). [3, 4]

Dosage and Administration:

The dosage of ACETAMEX 250 MG varies significantly depending on the condition being treated. It should always be determined by a physician. [3, 4, 5]

• For Glaucoma:
  • Chronic Simple (Open-Angle) Glaucoma: 250 mg to 1 gram daily, usually in divided doses.
  • Secondary Glaucoma: 250 mg every 4 hours.
  • Acute Congestive (Angle-Closure) Glaucoma: 250 mg every 4 hours, or a single dose of 500 mg to 1 gram.
• For Edema: Initial dose 250 mg to 375 mg once daily in the morning, or on alternate days.
• For Epilepsy (Adjunct): 8 to 30 mg/kg/day in divided doses. Typical adult dose is 250 mg to 1 gram daily.
• For Acute Mountain Sickness: 125 mg to 250 mg two to three times daily, started 1–2 days before ascent.
• Administration Method: Tablets should be swallowed whole with water. It can be taken with or without food.
• Note: Always tailor dosage based on renal function, age, and indication.

Contraindications:

ACETAMEX 250 MG is contraindicated in: [3, 4, 5]

• Hypersensitivity to acetazolamide or sulfonamides.
• Severe renal or hepatic dysfunction (e.g., severe renal failure, cirrhosis, hepatic insufficiency).
• Adrenocortical insufficiency.
• Hyponatremia (low sodium levels).
• Hypokalemia (low potassium levels).
• Hyperchloremic acidosis.
• Long-term use in chronic non-congestive angle-closure glaucoma.
• Not recommended in neonates or infants under 2 months without medical supervision.

Warnings and Precautions:

• Electrolyte Imbalance: Acetazolamide can cause electrolyte disturbances, particularly hypokalemia and hyponatremia. Regular monitoring of serum electrolytes is essential, especially in elderly patients or those on concomitant medications that affect electrolyte balance. [3, 4]
• Metabolic Acidosis: Prolonged use can lead to metabolic acidosis, particularly in patients with COPD or renal dysfunction. [3, 4]
• Renal Calculi (Kidney Stones): Increased risk of kidney stone formation, especially with long-term use. Adequate hydration is important. [3, 4]
• Sulfonamide Allergy: Patients with a history of sulfonamide allergy may be at increased risk of hypersensitivity reactions. [3, 4]
• Blood Disorders: Rare but serious blood disorders (e.g., aplastic anemia, agranulocytosis, thrombocytopenia) have been reported. Regular blood counts are advisable during prolonged therapy. [3, 4]
• Liver Disease: Use with extreme caution in patients with liver disease, as it can precipitate hepatic encephalopathy. [3, 4]
• CNS Effects: May cause drowsiness, dizziness, confusion, or depression. Patients should be cautioned against driving or operating machinery until they know how they react to the medication. [3, 4]
• Pregnancy Category C: Use only if clearly needed and the potential benefits outweigh the risks. [3, 4]
• Not recommended for prolonged use without monitoring.

Pharmacokinetics:

• Absorption: Rapidly absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations are usually reached within 1-3 hours. [3, 4]
• Distribution: Widely distributed in body tissues, particularly in red blood cells, kidneys, and central nervous system. It is highly bound to plasma proteins. [3, 4]
• Metabolism: Acetazolamide is not significantly metabolized in the body. [3, 4]
• Elimination: Excreted primarily unchanged in the urine by renal tubular secretion. The elimination half-life is approximately 2.4 to 5.8 hours. [3, 4]

Side Effects:

Common side effects of Acetazolamide include: [3, 4]

• Neurological: Paresthesia (tingling or numbness in extremities), headache, dizziness, fatigue, drowsiness, confusion.
• Gastrointestinal: Nausea, vomiting, diarrhea, loss of appetite, metallic taste.
• Renal: Increased urination, kidney stones.
• Metabolic: Electrolyte imbalances (hypokalemia, hyponatremia), metabolic acidosis.
• Other: Allergic reactions (rash, fever), photosensitivity, transient myopia (nearsightedness), tinnitus.

Serious but rare side effects include severe hypersensitivity reactions (e.g., Stevens-Johnson syndrome), blood dyscrasias (e.g., aplastic anemia, agranulocytosis), and hepatic dysfunction. Seek immediate medical attention if any severe or persistent side effects occur.

Drug Interactions:

Acetazolamide can interact with several medications: [3, 4]

• Aspirin (high doses): Concomitant use with high-dose aspirin can lead to increased levels of acetazolamide and salicylate toxicity, increasing the risk of severe acidosis.
• Lithium: May increase lithium excretion, reducing its therapeutic effect.
• Other Diuretics/Digoxin: Increased diuretic effect and risk of electrolyte disturbances.
• Antiepileptics (e.g., Phenytoin, Carbamazepine): May alter levels of some anticonvulsants.
• Cyclosporine: May increase cyclosporine levels.
• Amphetamines and Quinidine: Acetazolamide can increase the reabsorption of basic drugs like amphetamines and quinidine, potentially increasing their effects.
• Metformin: May increase the risk of lactic acidosis.
• Corticosteroids: May increase the risk of hypokalemia.

Patient Counseling:

• Take ACETAMEX exactly as prescribed by your doctor. Do not stop taking it without consulting your doctor, especially if used for epilepsy.
• Drink plenty of fluids to help prevent kidney stones.
• Report any unusual tingling, numbness, fatigue, severe nausea, sore throat, unusual bruising, or changes in vision to your doctor.
• Be aware of potential dizziness or drowsiness, and exercise caution when driving or operating machinery.
• Inform your doctor about all other medications, supplements, and herbal products you are taking.
• Avoid alcohol while on treatment.
• Store the medication at room temperature, away from moisture and heat, and out of reach of children.

Sources:

• HI-PHARM Official Website: https://www.hipharm.com.eg/ [1]
• HI-PHARM Product Catalog (search for Acetamex): https://www.hipharm.com.eg/products/ [2]
• Acetazolamide - Summary of Product Characteristics (SmPC) - Medicines.org.uk: https://www.medicines.org.uk/emc/product/1000/smpc [3]
• Acetazolamide - DrugBank Online: https://go.drugbank.com/drugs/DB00819 [4]
• Acetamex 250 mg Tabs - Egyptian Drug Directories (e.g., Dawaa.org, Med.tn): https://dw2.org/drug/acetamex-250-mg-20-tabs [5]